Trial reportAIDS (London, England)2010
Prevention of tuberculosis in Bacille Calmette-Guérin-primed, HIV-infected adults boosted with an inactivated whole-cell mycobacterial vaccine.
Trial report in AIDS (London, England), 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00052195 (DARDAR Health Project), which is not on this map. Cited by 93 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
DARDAR Health Project (Disseminated Tuberculosis and HIV Infection)
Who cites it
93 citing papers in PubMed, 1 synthesis or guideline pooled it, 219 citations in OpenAlex.
- Vaccine against tuberculosis: what's new?BMC infectious diseases · 2014Pooled it
- Safety and protective efficacy of PfSPZ Vaccine administered to HIV-negative and -positive Tanzanian adults.The Journal of clinical investigation · 2024Trial
- The potential of CBC-derived ratios (monocyte-to-lymphocyte, neutrophil-to-lymphocyte, and platelet-to-lymphocyte) to predict or diagnose incident TB infection in Tanzanian adolescents.BMC infectious diseases · 2020Trial
- CD4+ T cell cytokine responses to the DAR-901 booster vaccine in BCG-primed adults: A randomized, placebo-controlled trial.PloS one · 2019Trial
- Phase 2b Controlled Trial of M72/AS01The New England journal of medicine · 2018Trial
- Altruism, Scepticism, and collective decision-making in foreign-born U.S. residents in a tuberculosis vaccine trial.BMC public health · 2018Trial
- Trial
- A Randomized, Controlled Safety, and Immunogenicity Trial of the M72/AS01 Candidate Tuberculosis Vaccine in HIV-Positive Indian Adults.Medicine · 2016Trial
- Safety, immunogenicity, and efficacy of the candidate tuberculosis vaccine MVA85A in healthy adults infected with HIV-1: a randomised, placebo-controlled, phase 2 trial.The Lancet. Respiratory medicine · 2015Trial
- Intracellular Cytokine Staining and Flow Cytometry: Considerations for Application in Clinical Trials of Novel Tuberculosis Vaccines.PloS one · 2015Trial
- Safety and reactogenicity of BCG revaccination with isoniazid pretreatment in TST positive adults.Vaccine · 2014Trial
- Trial
- Greater preexisting interferon γ responses to mycobacterial antigens and lower bacillary load during HIV-associated tuberculosis.The Journal of infectious diseases · 2013Trial
- Randomized, placebo-controlled phase II trial of heat-killed Mycobacterium vaccae (Longcom batch) formulated as an oral pill (V7).Human vaccines & immunotherapeutics · 2013Trial
- Increased mortality associated with treated active tuberculosis in HIV-infected adults in Tanzania.Tuberculosis (Edinburgh, Scotland) · 2013Trial
- A phase IIa trial of the new tuberculosis vaccine, MVA85A, in HIV- and/or Mycobacterium tuberculosis-infected adults.American journal of respiratory and critical care medicine · 2012Trial
- Polyantigenic interferon-γ responses are associated with protection from TB among HIV-infected adults with childhood BCG immunization.PloS one · 2011Trial
- Immunogenicity of a protective whole cell mycobacterial vaccine in HIV-infected adults: a phase III study in Tanzania.Vaccine · 2010Trial
- Low BMI and falling BMI predict HIV-associated tuberculosis: a prospective study in Tanzania.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2010Trial
- Safety of the M72/AS01 Tuberculosis Vaccine in People Living With HIV: A Systematic Review and Meta-Analysis.Open forum infectious diseases · 2026Article
33 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 6 institutions in 2 countries.
Funding
Abstract
objectiveTo determine whether a multiple-dose series of an inactivated whole cell mycobacterial vaccine, Mycobacterium vaccae, can prevent HIV-associated tuberculosis. DESIGN AND
methodsThe DarDar trial was a randomized, placebo-controlled, double-blind trial. The study was carried in an outpatient facility in Dar es Salaam, Tanzania. HIV-infected patients with CD4 cell counts of at least 200 cells/microl and a Bacille Calmette-Guérin scar were chosen for the study. The intervention was carried out by random 1:1 assignment to five intradermal doses of M. vaccae or placebo. Tuberculin skin tests were performed, and patients with reactions of at least 5 mm were administered isoniazid for 6 months. The main outcome measures were disseminated (primary endpoint), definite, and probable tuberculosis (secondary endpoints).
resultsTwo thousand thirteen individuals were randomized (1006 to M. vaccae, 1007 to placebo) and followed every 3 months for a median of 3.3 years. The trial was terminated early because of slow accrual of cases of disseminated tuberculosis and significant protection against definite tuberculosis. Hazard ratios were disseminated tuberculosis 0.52 (95% confidence interval 0.21-1.34; seven cases in M. vaccae, 13 cases in placebo; log-rank P = 0.16), definite tuberculosis 0.61 (95% confidence interval 0.39-0.96; 33 cases in M. vaccae, 52 cases in placebo; P = 0.03), and probable tuberculosis 1.17 (95% confidence interval 0.76-1.80; 48 cases in M. vaccae, 40 cases in placebo; P = 0.46). Immunization was well tolerated, with no adverse effect on CD4 cell count or HIV viral load, and no increase in the rate of serious adverse events.
conclusionAdministration of a multiple-dose series of M. vaccae to HIV-infected adults with childhood Bacille Calmette-Guérin immunization is safe and is associated with significant protection against definite tuberculosis. These results provide evidence that immunization with a whole cell mycobacterial vaccine is a viable strategy for the prevention of HIV-associated tuberculosis.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.